By Fineline Cube 
China-based Fujian Cosunter Pharmaceutical Co., Ltd. (SHE: 300436) announced that it has received ethical approval from Shulan (Hangzhou) Hospital to initiate a randomized, double – blinded, placebo – controlled, multi – center Phase III study for its neracorvir (GST – HG141) as add – on therapy for chronic hepatitis B (CHB) patients with suboptimal response to antiviral treatment.
First-in-Class Mechanism and Profile
Neracorvir is a first – in – class hepatitis B core protein/capsid modulator with a novel mechanism of action, positioning it as a potential best – in – class investigational drug for HBV treatment. Currently, no similar product has been approved anywhere globally.
Clinical Data and Efficacy
Phase Ib/II clinical data demonstrated neracorvir’s rapid onset of action, superior efficacy, and favorable safety profile. When combined with nucleoside analogs, it showed enhanced HBV DNA suppression, significant reduction in HBV pgRNA levels, and potential cccDNA inhibition/depletion effects.
Regulatory Recognition
The drug was designated as a “Breakthrough Therapy” by China’s National Medical Products Administration (NMPA) in December 2024, underscoring its potential to address an unmet medical need in the treatment of chronic hepatitis B.-Fineline Info & Tech